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Bloomberg Business: The FDA Recall System is Voluntary and Broken

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Bloomberg Business recently published a comprehensive look at how patients suffer when drug manufacturers and regulators fail to protect them and effectively recall dangerous drugs from their medicine cabinets.

For the past 25 years, the experienced drug injury lawyers at Cory Watson have helped thousands of victims hurt because of dangerous medical devices and unsafe drugs released without accurate testing.

“If you think the FDA is a true watchdog over the safety of drugs put into the marketplace, you are wrong,” said Ernest Cory, managing shareholder of Cory Watson Attorneys. “The FDA only gets what the drug manufacturer wants them to see. And too often, they don’t get the whole story until the product has come onto the marketplace and injured many victims.”

Contact us today for a free, confidential case review – Call (877) 562-0000 now or fill out the online consultation form on this page.

Zantac Recalled for Carcinogen Contamination

In September 2019, the U.S. Food and Drug Administration received a 19-page document with startling claims about a popular medicine.

Researchers at Valisure, a Connecticut lab that tests prescription drugs, found extremely high levels of a probable human carcinogen in the antacid ranitidine, best known under the brand name Zantac.

Millions of people around the world use ranitidine; it’s available both with a prescription and over the counter. As for the carcinogen, NDMA, the FDA knew it well: For more than a year, the agency had been recalling batches of the blood pressure medication Valsartan contaminated with it.

The FDA issued an alert that seemed to downplay the lab’s findings. The agency said it had learned that some ranitidine medicines contained low levels of NDMA, but it wasn’t advising people to stop taking the drug. Those with prescriptions could contact their doctors — if they were worried — and everyone else could consider alternatives on drugstore shelves.

However, high levels of NDMA were found in every version of ranitidine tested, and labs concluded the problem was inherent to the molecule itself. In other words, there is no safe version of ranitidine.

The FDA’s Limited Authority Over Recalls

By mid-October, a month after the FDA’s alert, at least two dozen countries had pulled ranitidine from stores or halted its distribution. Numerous companies acted on their own to slow or stop the supply of the drug. The FDA continued to conduct tests.

43 jurisdictions and governments around the world took action before the United States did.

Finally, on November 1, the agency announced that it had found higher-than-acceptable levels of NDMA in some ranitidine. The FDA then asked manufacturers to voluntarily recall some of the Zantac on the market.

When the FDA finds that a drug’s quality is compromised, recalls are supposed to reverse the supply chain and remove the affected product from warehouses, pharmacy shelves, and patients’ medicine cabinets.

But the agency’s authority over this system is limited. It can only request a pullback – the manufacturers can say no, and they often refuse. The FDA can’t contact patients directly; it relies on pharmacies for that. It also doesn’t control how the recall is conducted or how its effectiveness is assessed.

A probable carcinogen in a medication taken by millions of people, manufactured in a factory that the FDA knew had problems, is a crisis for the agency. An effective recall system is crucial to prevent further injuries.

How Do You Stop Taking a Recalled Medication If You Don’t Know It’s Been Recalled?

Patients using Valsartan and Zantac were supposed to be notified by their pharmacies that their drugs could be dangerous. Those notifications didn’t always happen.

Old mailing addresses, a switch in pharmacies or the use of more than one, and failure to distinguish a recall letter from junk mail can all interfere with alerting patients to dangerous drugs.

There are also gaps in the flow of information, especially when drugs are recalled in batches identified by manufacturers’ lot numbers, as is common practice. Meanwhile, the number of anxious patients mounts.

The failure of that system can be seen in the client base of plaintiffs’ attorney Ernest Cory of Cory Watson, a firm representing hundreds of people who took the potentially-tainted drugs. Many of his clients hadn’t been warned of the FDA recall, and only found out on through the news, social media, or through attorney advertising.

Don’t Sit On Your Rights

The experienced drug injury attorneys at Cory Watson are evaluating the claims of hundreds of people with cancer – liver, stomach, intestinal, colon, pancreatic, or kidney – who took these drugs.

Hundreds of lawsuits have been filed against Valsartan and Zantac drug manufacturers involved in the recalls. If you or a loved one developed cancer after taking these drugs, call today for your FREE case evaluation. Call (877) 562-0000 or fill out the online case consultation form on this page.

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